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Validation Engineer with Manufacturing

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Work from:

Offer summary

Experience in medical device manufacturing, Knowledge of FDA and ISO requirements.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities:

Experience in supporting medical device manufacturing.
Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
Validation Experience, especially cleaning
Processes experience, molding, cleaning, packaging
Specific experience with Test method Validation and Gage R&R
Experience with root cause analysis and problem-solving for both technical and process issues
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
Good problem-solving skills through the use of quality and statistical tools, Six Sigma
Ability to read and understand engineering drawings.
Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
Knowledge of Quality System requirements, ISO and FDA requirements
Ability to effectively work within a cross-functional team to complete critical project tasks.
Demonstrates good written and verbal communication skills.
Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions and proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts.